Stockert 3T heater cooler system lawsuits are being filed on behalf of individuals diagnosed with a serious infection, non-tuberculous mycobacteria (NTM), as a result of the use of a heater-cooler system during open-chest surgery. According to an analysis of heater-cooler units in the U.S. and Canada, 1 in 3 heater cooler devices tested positive for the bacteria M. chimaera.
December 13, 2018 – 3T Heater-Coolers Heart Surgery Infection Lawsuits Ordered To Settlement
85 product liability lawsuits are currently active against the manufacturer of the heater-cooler system. These lawsuits have been centralized in a federal MDL before Judge Jones in the Middle District of Pennsylvania.
Stockert 3T Heater-Cooler Lawsuits
Several heater cooler lawsuits have been filed against the device manufacturer Liva Nova PLC (formerly Sorin Group Deutschland GmbH) on behalf of individuals diagnosed with M. Chimaera after having open-heart surgery. The lawsuit alleges that the device was designed and manufactured with defects that were recognized as a potential source of infection as early as 2002.
Furthermore, the 3T Stockert heater-cooler system lawsuit alleges that even though Liva Nova PLC knew or should have known of these defects, they failed to warn patients and medical providers of the risk. In fact, there have been 15 versions of the “instructions for use” (IFU) sent to medical professionals with the Stockert 3T heater-cooler device and none of them have a validated cleaning and disinfection procedure.
Of the 16 heater-cooler lawsuits that have been filed in six different districts, 10 of the cases are being informally coordinated in a South Carolina federal court, and six actions are pending outside of South Carolina.
The heater-cooler lawsuits make common allegations that the plaintiffs were exposed to M. chimaera or M. abscessus, types of non-tuberculous mycobacteria (NTM) after undergoing surgery utilizing the 3T Heater-Cooler system. While some patients do not become ill from NTM exposure, those with a weak immune system may contract a slowly progressive and destructive disease that may become chronic and require ongoing medical treatment.
Stockert 3T Heater-Cooler Linked to Infection
The FDA and CDC are warning patients and providers about the potential risk of infection from the Stockert 3T Heater-Cooler System used during open-chest surgeries involving the heart, lung or liver. More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler devices are an essential part of these surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure, yet most patients are not aware of the device’s usage.
For this reason, the CDC and the FDA are now warning patients who had cardiothoracic surgeries which can include the heart, liver or lung to seek medical care if they are experiencing symptoms associated with infections that could indicate they were exposed to M. Chimaera, a dangerous form of nontuberculous mycobacterium (NTM).
How Do Heater-Cooler Systems Work?
Heater cooler devices are used to control the temperature of patient’s blood and organs during approximately 60 percent of open heart surgeries performed in the U.S. The system circulates water through tubes into a heat exchanger to keep the patient warm, but tainted water from inside the unit can be circulated into operating room air, where it can contaminate the exposed surgical site of the patient.
According to John Rihs, VP of Laboratory Services at Special Pathogens laboratory, “some of the devices remained positive for M. chimaera for months indicating that disinfection can be difficult.”
Rihs delivered the alarming news of the link between M. chimaera and heater-cooler units at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC). Rih’s analysis was based on a study of 89 heater cooler units in 23 hospitals throughout Canada and the U.S. between July 2015 and December 2016. This same analysis found 1 in 3 heater cooler devices testing positive for the bacteria M. chimaera.
Stockert 3T Systems are heater-cooler devices that have water tanks providing temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the 3T System circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
FDA and CDC Suggest Hospitals Should Warn Patients of the Risk of Infection to Mitigate Risk
According to the CDC, approximately 60 percent of heart bypass procedures performed in the U.S. utilize the Stockert 3T device that has been associated with these infections.
On June 1, 2016, the FDA issued a Safety Communication noting the link between M. chimaera infections associated with the use of the 3T heater-cooler system. According to the FDA, devices produced prior to August 2014 were found to have M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. To date, the FDA is not aware of infections that occurred with 3T devices manufactured after September 2014.
In October 2016, the CDC estimated that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. The CDC and the FDA are continuing to evaluate this risk and we may see the number of individuals at risk grow as it takes a significant amount of time to develop symptoms of this deadly bacteria.
According to the Centers for Disease Control and Prevention (CDC), the substantial horizontal airflow generated by heater-cooler units might disrupt vertical ultraclean airflow, which could be a potential mechanism for transmission of pathogens from a contaminated heater-cooler unit to a surgical site.
The CDC released a Health Alert Network Advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk. Many hospitals have been sending out Patient Advisory Letters to warn of the potential risk of infection. The FDA is collaborating with “professional societies, public health partners, heater-cooler manufacturers, and infectious disease specialists to evaluate additional strategies for mitigating infections associated with heater-cooler devices.”
The agency is urging hospitals and medical clinics to use extreme caution when cleaning and disinfecting heater-cooler units, and also to ensure that they are using the most up-to-date version of the manufacturer’s instructions when doing so.
What is M. Chimaera?
M. chimaera is a deadly bacteria that is often found in soil and water but is rarely associated with infections. However, patients exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that often take months to emerge leading to misdiagnosis in many cases.
M. chimaera is fatal to nearly half the patients diagnosed with the bacteria.
M. Chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower. In addition, detecting M. Chimaera is difficult because patients may not develop symptoms or signs of infection for months to years after initial exposure. The first symptoms of the infection is an unexplained fever that lasts more than one week. Other symptoms of M. chimaera include:
- Low energy
- Night sweats
- Joint or muscle pain
- Redness, heat, or pus around the surgical incision
- Difficulty breathing
- A persistent cough
- A cough with blood
- Nausea and vomiting
M. chimaera is fatal to approximately half the people who contract the infection. According to the FDA, of the 32 cases occurring between 2010 and 2015, nearly half the patients died. All of these patients had surgeries utilizing the Stӧckert 3T heater-cooler system.
What Should You Do If You Had Cardiothoracic Surgery?
- Be aware! Most cardiopulmonary bypass procedures involve the use of a heater-cooler device.
- Talk to your doctor about your risk of exposure to M. chimaera,
- Recognize the signs and symptoms of NTM infection
- Contact your health care provider at the first sign of these symptoms
- Report any problems to the FDA
12 Children Infected During Surgery
The Children’s Hospital of New Orleans announced that at least twelve children who underwent cardiac surgery at Children’s Hospital between late May and July 2017 developed mycobacterium abscessus. According to the hospital statement, the children were infected by a piece of equipment used to regulate the temperature of patients while on bypass – a heater-cooler unit.
24 Cardiac Surgery Patients Diagnosed with Mycobacterium Infection In New Orleans Hospital
October 2016 – This was the largest amount of cases reported, and nearly half of the patients died from the infection. The infection is very serious and is also very slow to develop — meaning the link to cardiac surgery may not immediately be recognized.
Heater Cooler Lawsuit Frequently Asked Questions
Sometimes you need a lawyer near you and sometimes its best to hire a lawyer based on the lawyer’s resources and experiences.
The right lawyer for your heater-cooler lawsuit may not be your local lawyer, but instead, may be someone with the experience of a mass tort lawsuit. The heater-cooler lawsuit has not yet been consolidated into a mass tort lawsuit, but this may be a legal tool used later as more individuals learn of their infection and file lawsuits. Mass tort cases filed all over the country are often consolidated into a single courtroom in order to move the many lawsuits through the courts in the most effective and efficient way. A lawyer experienced with the multidistrict litigation process with the ability to represent clients in all 50 states, is likely to be a good fit for mass tort litigation.
TruLaw is not afraid to take on the largest drug and medical device companies in the world. We work with trusted legal affiliates to make sure that TruLaw clients have the resources and experiences needed to hold big business accountable when they put profits over people.
Heater Cooler System Lawsuit is a good resource for anyone that believes they were injured by a 3T systems cooler system and may be considering a Heater Cooler System class action or curious about future Heater Cooler System settlement.
M.Chimaera is a serious infection that will require ongoing medical care. TruLaw believes that victims should not be carrying the financial burden of this care, instead, the company that caused your injury should be held accountable.
A Stockert 3T heater-cooler lawsuit is designed to help you financially recover. Your lawsuit should assist in covering your medical bills, the amount of income and benefits that you lost as a result of your injury and, if your injuries are permanent, we will look to recover for your permanent disfigurement.
In addition, it is always our hope that your Stockert 3T heater-cooler lawsuit will help us to remove dangerous products like this one from the market. We are not only lawyers, but also safety advocates that believe in getting information out to the public so no more people are injured. We hope you will join us in the role as a safety advocate.
Currently, there have been no settlements in the heater-cooler M.Chimaera infection cases. Trulaw will continue to update this page as these lawsuits progress.
We understand the frustration in waiting to hear about settlements in product liability lawsuits. Unfortunately, in drug and device cases, we have no choice but to sue some of the most profitable companies in the world. Big Pharma has deep pockets and lawsuits are a cost of doing business for them. They are not inclined to settle until it makes business sense to them.
TruLaw lawyers building our cases with an eye on winning in court as well as settlement, when we believe that is the best result for our clients. We will never settle without advising you of your options, and we will keep you posted on our progress and the possibility of any heater cooler system settlement as we move forward.
We often hear injured people refer to their personal injury case as a “class action” because their case was grouped together in a lawsuit with other injured people. This is most often NOT the case. We are not filing a heater cooler system class action. Often, individual cases are grouped together so the attorneys and judge can address common procedural issues initially, saving time for the injured parties and the court, but this is very generally referred to as a “mass tort.”
On February 2, 2018, the Sorin 3T Heater-Cooler System Products Liability Litigation was consolidated into multidistrict litigation number 2816 and assigned to the Honorable John E. Jones, III. in the Middle District of Pennsylvania.
MDL is a procedural tool used when plaintiffs have incurred injuries from products manufactured by the same defendant(s), such as in the case of the Stockert 3T heater-cooler. Even though each plaintiff filing a lawsuit against Stockert, may experience different symptoms of M.Chimaera, the facts of how and why the individual was infected are similar so it may make sense to consolidated these cases. Even if consolidation under an MDL occurs, TruLaw treats each plaintiff’s injuries different.
It is important to understand that mass tort cases are an effective tool to getting the attention of the large drug and device companies. MDLs assist lawyers in determining exactly what the drug and device companies knew about the risks their products caused and whether or not they should have warned consumers. Too often, consumers believe that they can file a single lawsuit and get the attention of big drug companies. This is very hard to do.
Technically, MDLs do not happen until a judicial panel transfers individual cases to a single court. Depending on when your lawsuit is filed, you may find yourself automatically transferred to the MDL court or you may wait to learn when and if the JPML believes an MDL is the proper venue for the mass tort.
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